(Reuters) – Sage Therapeutics Inc and Biogen’s experimental drug improved symptoms of postpartum depression after 15 days in a late-stage study, the companies said on Wednesday.
The drug, zuranolone, also reduced depression severity as early as the third day of treatment compared with placebo in the study conducted among 200 adult women, clozaril q according to a company press release (https://bit.ly/3tbG9T4).
Zuranolone, Sage’s most advanced drug candidate, is an oral neuroactive steroid GABA-A receptor positive allosteric modulator that is being developed for the treatment of major depressive disorder as well. It improved depression symptoms in two late-stage studies, but there have been concerns about its effectiveness and durability.
Analysts have said the near-term durability of the oral drug would be important for its broader commercial success and expressed concerns about whether its data in MDD would limit market opportunity.
While Wednesday’s announcement bodes well for zuranolone, postpartum depression is a smaller market opportunity than major depressive disorder, said Truist Securities analyst Robyn Karnauskas.
The target population for major depressive disorder is higher than postpartum depression, but the latter’s “competitive intensity is much lower”, Sage Chief Innovation Officer Jeff Jonas told Reuters.
About 1 in 8 women experience symptoms of postpartum depression, according to the U.S. Centers of Disease Control and Prevention (CDC).
A previous late-stage study testing a lower dose of zuranolone for postpartum depression had also met the main goal, according to the company.
Sage signed a deal worth up to $1.5 billion with Biogen in 2020 to develop zuranolone along with another experimental drug.
The companies started submitting data on the drug to the U.S. health regulator for the treatment of major depressive disorder earlier this month and expect to complete the marketing application in the second half of the year.
They expect to file for the drug’s approval for postpartum depression early next year.
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